# US 12,178,746 B2 · Pain management using cryogenic remodeling

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- Number: US 12,178,746 B2
- Document ID: US12178746B2
- Status: Granted
- Kind: B2
- Application number: 18/141,865
- Filed: 2023-05-01
- Published: 2023-08-24
- Granted: 2024-12-31
- Earliest claimed: 2007-11-14
- Assignees: Pacira CryoTech, Inc.
- Applicants: Pacira CryoTech, Inc.
- Inventors: Keith Burger; Lisa Elkins; Ronald Williams
- Web page: https://patentgrep.com/patent/US12178746B2

## CPC

- A61F 7/12: Devices for heating or cooling internal body cavities
- A61B 18/0218: {with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip}
- A61F 7/00: Heating or cooling appliances for medical or therapeutic treatment of the human body (hyperthermia using electric or magnetic fields or ultrasound A61N)
- A61B 2018/00452: {Skin}
- A61B 2018/0293: {using an instrument interstitially inserted into the body, e.g. needle}
- A61F 2007/0056: {for cooling}
- A61F 2007/0063: {for cooling}
- A61F 2007/0087: {Hand-held applicators}
- A61F 2007/0094: {using a remote control}
- A61F 2007/0285: {Local anaesthetic effect}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Medical devices, systems, and methods for pain management and other applications may apply cooling with at least one probe inserted through an exposed skin surface of skin. The cooling may remodel one or more target tissues so as to effect a desired change in composition of the target tissue and/or a change in its behavior, often to interfere with transmission of pain signals along sensory nerves. Alternative embodiments may interfere with the function of motor nerves, the function of contractile muscles, and/or some other tissue included in the contractile function chain so as to inhibit muscle contraction and thereby alleviate associated pain. In some embodiments, other sources of pain such as components of the spine (optionally including herniated disks) may be treated.

## Claims

### Claim 1

A method for treating a back pain associated with a target nerve of a patient, the method comprising:
inserting a distal end of a needle of a cryogenic system into a tissue beneath a skin surface of the patient, wherein the needle comprises a 16 gauge or smaller needle;
positioning a distal portion of the needle beneath the skin surface at a desired location in proximity to the target nerve associated with the back pain;
performing a first cooling cycle via the distal portion of the needle at the desired location in proximity to the target nerve associated with the back pain so that the needle cools tissue at the desired location; and
performing a second cooling cycle via the distal portion of the needle, wherein the cooling cycles are configured to reach temperatures less than −19 degrees Celsius, and wherein the cooling cycles sufficiently reduce back pain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the back pain comprises a lower back pain.

### Claim 3 (depends on 1)

The method of claim 1, wherein the back pain comprises facet joint pain.

### Claim 4 (depends on 1)

The method of claim 1, wherein the back pain comprises sacroiliac joint pain.

### Claim 5 (depends on 1)

The method of claim 1, wherein the desired location comprises a branch nerve from the spinal column.

### Claim 6 (depends on 1)

The method of claim 1, wherein the target nerve comprises sensory nerves and wherein the cooling cycles inhibits transmission of pain signals along the sensory nerves.

### Claim 7 (depends on 1)

The method of claim 1, wherein positioning comprises guiding the distal portion of the needle to the desired location using fluoroscopy, ultrasound imaging, magnetic resonance imaging (MRI), or electromyography.

### Claim 8 (depends on 1)

The method of claim 1, wherein the second cooling cycle is performed at the desired location in proximity to the target nerve associated with the back pain.

### Claim 9 (depends on 1)

The method of claim 1, wherein the second cooling cycle is performed at a second location in proximity to a second target nerve associated with the back pain.

### Claim 10 (depends on 1)

The method of claim 1, wherein the needle comprises an array of two or more needles.

### Claim 11

A method for treating a back pain associated with a target nerve of a patient, the method comprising:
inserting a distal end of a needle of a cryogenic system into a tissue beneath a skin surface of the patient, wherein the needle comprises an electrically conducting structure at least partially surrounded by an electrical insulator, and wherein the distal end of the needle comprises an electrically conductive surface configured to be able to conduct electrical energy from an electrical source;
positioning a distal portion of the needle at a desired location in proximity to the target nerve associated with the back pain;
performing a first cooling cycle via the distal portion of the needle at the desired location in proximity to the target nerve associated with the back pain so that the needle cools tissue at the desired location; and
performing a second cooling cycle via the distal portion of the needle, wherein the cooling cycles are configured to reach temperatures less than −19 degrees Celsius, and wherein the cooling cycles sufficiently reduce back pain.

### Claim 12 (depends on 11)

The method of claim 11, wherein the back pain comprises a lower back pain.

### Claim 13 (depends on 11)

The method of claim 11, wherein the back pain comprises facet joint pain.

### Claim 14 (depends on 11)

The method of claim 11, wherein the back pain comprises sacroiliac joint pain.

### Claim 15 (depends on 11)

The method of claim 11, wherein the desired location comprises a branch nerve from the spinal column.

### Claim 16 (depends on 11)

The method of claim 11, wherein the desired location comprises a spinal cord adjacent an epidural space.

### Claim 17 (depends on 11)

The method of claim 11, wherein the desired location comprises a herniated disk.

### Claim 18 (depends on 11)

The method of claim 11, wherein the desired location comprises spinal tissue adjacent a vertebra.

### Claim 19 (depends on 11)

The method of claim 11, wherein the target nerve comprises sensory nerves and wherein the cooling cycles inhibits transmission of pain signals along the sensory nerves.

### Claim 20 (depends on 11)

The method of claim 11, further comprising stimulating the target nerve via the electrically conductive surface to locate the target nerve.

### Claim 21 (depends on 11)

The method of claim 11, wherein the second cooling cycle is performed at the desired location in proximity to the target nerve associated with the back pain.

### Claim 22 (depends on 11)

The method of claim 11, wherein the second cooling cycle is performed at a second location in proximity to a second target nerve associated with the back pain.

### Claim 23 (depends on 11)

The method of claim 11, wherein the needle comprises an array of two or more needles.